Saturday, January 22, 2011

On January 20, 2011, two NGOs filed "the most comprehensive legal action ever taken to protect endangered species from harmful pesticides. In the filing, the Center for Biological Diversity (CBD) and Pesticide Action Network North America (PANNA) accuse the USEPA of "registering and approving hundreds of pesticides known to harm imperiled species" without appropriate consultation with federal wildlife agencies. The lawsuit "seeks protection for 214 threatened or endangered species in 49 states and two U.S. territories."

The Endangered Species Act (ESA) requires EPA to undertake a formal consultation with other appropriate agencies responsible for protection of fish and wildlife, e.g., the Fish and Wildlife Service and the National Marine Fisheries Service (commonly referred to as simply, "the services"). Over the years EPA has determined in many cases that the risk did not rise to the level of requiring outside consultation and that EPA had sufficient authority and practices under the FIFRA pesticide law to act. However, CBD and PANNA charge that this practice is in violation of the ESA and favors the continued registration of pesticides that the services might otherwise deem to be too hazardous to fish and wildlife.

According to CBD,

The lawsuit seeks protection for 214 endangered and threatened species throughout the United States, including the Florida panther, California condor, piping plover, black-footed ferret, arroyo toad, Indiana bat, bonytail chub and Alabama sturgeon. Documents from the U.S. Fish and Wildlife Service and EPA, as well as peer-reviewed scientific studies, indicate these species are harmed by the pesticides at issue. More than a billion pounds of pesticides are used annually in the United States, and the EPA has registered more than 18,000 different pesticides for use. Extensive scientific studies show widespread and pervasive pesticide contamination in groundwater, drinking water and wildlife habitats throughout the country.

CBD and others have successfully sued EPA in the past, forcing the agency to consult with the services and often resulting in the further limitation of pesticide use. But "today’s litigation is the first on this scale, as it seeks nationwide compliance for hundreds of pesticides on hundreds of species"

An interactive map is available on the CBD web site. Clicking on a state will bring up a list of endangered and threatened species that CBD and PANNA identify in their law suit as being at risk due to EPA's lack of consultation with the services.

Friday, January 21, 2011

Reform of the ancient (in regulatory terms) Toxic Substances Control Act seemed to be finally on the front burner during 2010. After years of promising, the Democratic-led House and Senate each introduced bills. The House, led by Energy and Commerce Committee Chair Henry Waxman and subcommittee chair Bobby Rush, even held a series of meetings with stakeholders. This in addition to several public hearings on both the House and Senate side.

And then came the election.

The question now is a matter of priority. With the Republican party gaining control of the House, Representative Waxman is no longer chair (he becomes ranking member). Instead the committee, which has a broad oversight mandate, is being chaired by Republican Representative Fred Upton who has stated that he will focus on repealing the health care law passed in the last Congress (a vote was held this week), "fighting rampant regulations," and reducing spending, including that of the EPA.

In short, no one seems to know at this point whether the committee will get around to addressing TSCA reform, or for that matter, whether TSCA reform bills will even be reintroduced. On the Senate side the Democrats still have control and thus still chair the various committees. Long-time TSCA reform champion Senator Frank Lautenberg has stressed that he plans to reintroduce his "Safe Chemicals Act," but he didn't provide a timetable. Even if he does there would need to be a bill introduced on the House side, and right now it is not a very high priority for Representative Upton or Speaker Boehner. So we will have to wait.

While that happens the NGOs have redoubled their efforts to push TSCA reform legislation, and barring action on the federal level are pursuing state level actions. But as a commenter on my post yesterday pointed out, the past election resulted in strong conservative gains in many state legislatures, which along with continuing fiscal uncertainty, is likely to limit the ability of states to pick up the slack. Meanwhile, the message coming from industry has generally been that they prefer federal level modernization of TSCA rather than a patchwork of state regulations, either on individual chemicals (including bans) or as "TSCA Reform Lite." And while some parts of industry, e.g., larger companies, may be comfortable with greater health and safety disclosure since they may have already compiled the data for REACH, other parts of industry argue that they are less capable of handling extensive data submission demands on, e.g., lower volume chemicals. These special "small and medium sized entities" issues were addressed to some extent in the legislation proposed in 2010, but it remains unclear what form any new legislation may take. In short, there are a lot of issues still to be worked out should Congress decide to move forward.

I would not expect any activity on TSCA before summer or even fall, and after that the dynamics of a presidential election year may distract members of Congress from issues like TSCA reform. So we will have to wait and see.

Thursday, January 20, 2011

With TSCA reform activities essentially dormant (and perhaps dead), a total of 30 separate US states have introduced chemical reform legislation. According to the advocacy NGO Safer Chemicals, Healthy Families, "on Wednesday, January 19, legislators and advocates in thirty states across the country and the District of Columbia will announce legislation aimed at protecting children and families from harmful chemicals." They also claim that "despite well-funded opposition from the chemical industry, 18 state legislatures have already passed 71 chemical safety laws in the last eight years by an overwhelming, bipartisan margin – with more to come this year."

Last year both the House and Senate introduced "Safe Chemical" bills in an attempt to modernize the 34-year old Toxic Substances Control Act. While on the House side there were several stakeholder meetings held to get input so that the bills could be fine-tuned, no substantive action occurred in committee in an effort to get votes on the bills. Which means they must be reintroduced in this new Congress. With the Republicans gaining control in the House and narrowing the gap in the Senate, along with the continuing lagging (though improving) economy, it is unclear whether any federal level TSCA reform can get passed this year or next.

With that in mind NGOs are shifting their efforts to encouraging state level action. According to the NGO's press release:

"The American public is demanding new chemical safety laws, and state elected officials – both Republicans and Democrats – are responding," said Andy Igrejas, Campaign Director of the Safer Chemicals, Healthy Families coalition. "At some point Congress will wake up and realize it is better for industry and public safety to make these changes at the federal level, as well."

Planned legislation includes comprehensive state laws in nine states, phase outs of the plasticizer BPA in at least 17 states, calls for federal action in at least 11 states, bans of cadmium in childrens products, and exposure reductions in at least three states to a brominated flame retardant. More information is available on the SCHF web site.

Wednesday, January 19, 2011

Okay, so it was just a little bit off. On January 4, 2011 the European Chemicals Agency (ECHA) announced with fanfare that 3.1 million classification and labeling (CLP) notifications had been received, and that these covered a total of 24,529 substances. Yesterday ECHA announced, with a bit of flush to their faces, that they miscounted - the number of substances covered by those notifications was actually 101,067!

The problem stems from the rush counting (after all, the announcement was less than 24 hours after the notification deadline). It turns out that some of the bulk files received were counted as single substances when in fact they were notifications of many distinct substances. Hence the quadrupling of the initial substance count.

Of course, the number will continue to rise as any hazardous substance that manufacturers or importers place on the market must submit CLP notifications prior to doing so.

Tuesday, January 18, 2011

The first 25,000 registration dossiers under REACH - for nearly 3,400 chemicals - were submitted to the European Chemicals Agency (ECHA) by the November 30, 2010 deadline. Over 3.1 million classification and labeling notifications were received by the January 3, 2011 deadline. The next tier registration deadline is not until June of 2013. So now what? A lot, so while many companies are feeling a sense of relief from meeting the deadlines they should not get too comfortable.

ECHA has a statutory requirement to review a minimum of 5% of the REACH registration dossiers submitted. Sure, that's only about 1,250 dossiers, right? Not so fast. The 5% figure is a minimum. ECHA could conceivably review 100% of the dossiers if they wanted to, assuming they could come up with the time and manpower resources (which is highly unlikely). But many of the dossiers submitted contain "Annex IX and X testing proposals." For those less familiar with REACH there are a series of Annexes that list the various test endpoints for which data must be provided. The endpoints listed in Annexes VII and VIII were required to be provided, including testing if necessary, along with the registration. But for Annexes IX and X, which include most of the longer-term, animal-intensive, test methods, registrants were required only to provide results they already had in-house but were banned from conducting any additional animal testing prior to submission. Instead they provided "testing proposals" indicating what additional Annex IX and X tests they planned to conduct.

What all this means is that ECHA must review all of the dossiers that include testing proposals in order to determine whether or not the proposed studies will actually inform their decision-making process. They will not allow animal testing if they think it will not change their decision. They also will insist that any testing be conducted in collaboration with other registrants in order to minimize animal testing. To do this they will publish a list of substances proposing testing and ask for anyone with available data to come forward. These third parties then have 45 days to provide valid data to address the endpoint, and assuming it fulfills the data requirement the registrants will have to pay the data holder for use of the existing data.

ECHA has until December of 2012 to respond to testing proposals received by the first registration deadline. Companies then will have a set period of time in which they must conduct the studies and update their registration dossier. The time frames will vary depending on the type and amount of testing since some studies could take 2 to 3 years to conduct.

Monday, January 17, 2011

The USEPA continues with its goal to increase transparency in government by launching a new web site called Reg Stat. The web site lets the general public keep track of the regulatory process and "the number, type, and range or regulatory documents developed each year by the agency." According to EPA:

EPA publishes roughly 2,000 documents in the Federal Register (FR) each year. Of the documents published each year, the majority are Notices. The Office of Policy (OP) has identified a subset of these as "Administrator-Signed Rules". EPA's Administrator-Signed rules are only those published actions which are signed by the Administrator and which modify or propose to modify the Code of Federal Regulations (CFR) and therefore, contain rule text. The data compiled and presented on this site primarily draws on this subset of rules signed by the EPA Administrator.

A key feature of the site is a set of graphs and charts to document how many rules are being signed, how long it takes to get through the various steps of each regulatory action, and the number of rules published in the Federal Register. There is also a link called "Regulatory Gateway" in which the public can see what EPA rulemaking, especially the priority rules, is currently in progress.

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